- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00076921
Epidemiology & Intervention Research for Tobacco Control
Research on China Tobacco Control Epidemiology and Intervention
Study Overview
Status
Conditions
Detailed Description
China is a particularly critical country for global tobacco control. It has the world's largest number of smokers, approximately 350 million, and the immense market afforded by the 60 percent of men who smoke and the 95 percent of women who do not smoke represents a prize target for the multinational tobacco companies. China has ratified the Framework Convention for Tobacco Control (FCTC) and now needs to implement its provisions across a large and diverse population. In this application, we propose a program of evidence-based community interventions to be implemented at the province and local levels with the overall objective of developing an approach for implementation nationally.
This application builds on a long-standing partnership between the Chinese Center for Disease Control and Prevention (China CDC), the Peking Union Medical College (PUMC) and the Johns Hopkins Bloomberg School of Public Health. That partnership began in 1995 with an agreement to collaborate on the conduct of China's 1996 national smoking survey. Our principal collaborator over those years, Dr. Gong-Huan Yang, is now Deputy Director of the China CDC and responsible for tobacco control at the national level. In the four years of funding to date from the Fogarty International Center (FIC), we have carried out a project in selected communities in three provinces, including urban and rural areas that provide a foundation for the intervention approach in this proposal. Specifically, we have carried out quantitative and qualitative studies to assess barriers to tobacco control and readiness for interventions, measured levels of airborne nicotine in key public environments, and developed capacity-building approaches. Our original FIC supported study involved three countries, China, Mexico and Brazil. However, this application will focus solely on China, as the latter two countries developed the necessary infrastructure and capacity to conduct research, publish their research findings, and seek further grants and government funding to sustain progress.
This application proposes a tobacco control study that will involve 7 provinces in a CDC-led initiative to develop a systematic mix of approaches. The plan uses strategies based on experiences from our work in China and from the American Stop Smoking Intervention Study for Cancer Prevention (ASSIST) and anticipates barriers that have been identified in the data collected to date. In the intervention provinces, the China CDC will team with the provincial-level CDCs to assess capacity for tobacco control and the current status of tobacco control, using an adapted version of the Strength of Tobacco Control (SOTC) index developed for evaluating ASSIST. This systematic characterization will highlight capacity needs. An extensive capacity development program, based in distance-based methods, will be used. We have the overall objective of preparing the China CDC to implement a proven approach to tobacco control at the national level. A household survey will be conducted and compared to the national survey results. Second-hand smoking will be assessed in selected locations in the 7 provinces.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare smoking rates and second-hand smoke exposure in 7 provinces to national data.
Time Frame: 3 years
|
A national household survey was conducted.
Provincial household surveys that adapted questions from the national survey were administered to gain provincial estimates.
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change or increase in number of tobacco control policies at the provincial level
Time Frame: 3 years
|
Policies in hospital, schools, worksites, government buildings, transportation facilities will be assessed to determine if they have implemented a policy.
|
3 years
|
Determine change in ability to conduct tobacco control strategies.
Time Frame: 3 years.
|
An assessment of the provinces ability or capacity to conduct tobacco control strategies were compared at baseline and at the end of the project.
|
3 years.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Frances Stillman, Johns Hopkins University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1209
- 5R01HL073699 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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